Dizal to Showcase Data in Hematologic Malignancies and Lung Cancer at ASCO 2025

• DZD8586 study results in B-cell non-Hodgkin lymphomas (B-NHLs) were selected for oral and poster presentations. The analysis in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after covalent or non-covalent BTK inhibitors and BTK degraders was selected for oral presentation
• Dizal will also present results from the ongoing Phase I/II study of DZD6008, a 4th generation EGFR TKI with full BBB penetration, in advanced EGFR mutation positive (EGFRm) non-small cell lung cancer (NSCLC)

SHANGHAI, April 24, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today that the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting will feature the latest study results from the company's investigational drugs DZD8586 and DZD6008 in B-cell non-Hodgkin lymphomas (B-NHLs) and non-small cell lung cancer (NSCLC).

The oral presentation includes results in B-NHLs from a pooled safety and efficacy analysis of two phase I/Ⅱ studies of DZD8586 in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with prior treatment of covalent and/or non-covalent BTK Inhibitors as well as BTK degraders.

While early clinical data showed encouraging anti-tumor activities from BTK degraders in CLL/SLL patients, resistance mutations to both BTK inhibitors and degraders have already been reported, and degrader-related toxicities may affect long-term clinical application. Data from Phase I/II studies of DZD8586 in CLL/SLL, presented at the 66th American Society of Hematology (ASH) Annual Meeting, showed that 94.4% of patients achieved tumor shrinkage at ≥50 mg QD. Significant tumor responses were also observed in other B-NHLs, including diffuse large B-cell lymphoma (DLBCL). Preliminary results from the ongoing phase Ⅱ study of DZD8586 monotherapy in patients with relapsed/refractory DLBCL will be presented at this ASCO meeting.

Dizal will also present Phase I/II data of DZD6008, a 4^th generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with full blood–brain barrier (BBB) penetration, in advanced EGFR mutation positive (EGFRm) NSCLC patients who failed prior 3^rd generation EGFR TKI treatment. Lung cancer is a leading cause of brain metastases (BMs), with 10-20% of patients with NSCLC presenting with BMs at diagnosis and 25-50% developing them over the course of their disease. NSCLC patients whose disease progressed after 3^rd generation EGFR TKI treatment often develop CNS metastasis and exhibit acquired EGFR resistance mutations. Preclinical data shows that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed 3^rd generation EGFR TKI therapy or multiple lines of pre-treatments.

"We are honored that our study results have been selected for oral presentations at ASCO for three consecutive years. Our presence at this congress highlights our commitment to addressing global unmet medical needs in hematological malignancies and lung cancer," said Xiaolin Zhang, PhD, CEO of Dizal. "We look forward to sharing positive clinical data of our novel medicines, which have the potential to bring clinical benefit to patients with limited treatment options."

Dizal presentation details during ASCO 2025：

About DZD8586
DZD8586 is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed as a potential treatment option for B-cell non-Hodgkin lymphoma (B-NHL).

While Bruton's Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can arise through two major mechanisms: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Currently, there is no targeted therapy available to address both resistance mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging efficacy in early clinical studies, mutation-related resistance has been reported, and degrader-related toxicities may affect long-term clinical application.

DZD8586 has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-NHLs in cell lines and in animal models. Phase I clinical trial suggests that DZD8586 exhibits favorable PK properties, good central nervous system (CNS) permeability, complete blockade of BCR signaling, and encouraging anti-tumor efficacy with good safety and tolerability in patients with B-NHL.

About DZD6008
DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI, designed as a potential treatment option for advanced EGFR mutation positive (EGFRm) NSCLC.

Non-small cell lung cancer is the leading cause of cancer death in the world. Epidermal growth factor receptor (EGFR) gene is one of the most common driver genes for NSCLC. Multiple agents can be used to treat patients with EGFR mutated NSCLC who develop resistance to EGFR tyrosine kinase inhibitors (TKIs), but the clinical outcome was not satisfactory. Brain metastases (BM) are a leading cause of death and disease progression for NSCLC. Approximately 23%-30% of NSCLC patients are synchronous BM at their initial diagnosis. Previous studies reported that the 3-year cumulative rate of BMs ranges from 29.4% to 60.3% in patients with mutated EGFR.

Currently, the clinical benefits of existing treatments for third-generation EGFR TKI-resistant NSCLC are limited and DZD6008 is expected to fill the unmet medical needs. DZD6008 effectively inhibits EGFR-mutated tumor growth in cell lines and in animal models. Previous clinical studies have validated the design concept of the molecule and suggest that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed third-generation EGFR TKI therapy or multiple lines of pre-treatments.

About Dizal
Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deeply rooted in translational science and molecular design, it has established an internationally competitive portfolio with two leading assets in global pivotal studies, both of which have already been launched in China.

To learn more about Dizal, please visit www.dizalpharma.com, or follow us on Linkedin or X.

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